In addition to clinical development activities, BDSI also made an important stride forward in building its pipeline of products for the treatment of pain with the acquisition of patented Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). BDSI entered into a worldwide licensing agreement with privately held Arcion, where BDSI will develop and commercialize Clonidine Topical Gel.
The effectiveness of Clonidine Topical Gel was previously assessed in reducing pain in PDN in a double-blind, placebo-controlled, Phase 2 study. A significant treatment difference was seen in the pain intensity (p=0.01, n=63) in the planned subset analysis of diabetic patients who had documented evidence of functioning pain receptors in the skin of the lower leg. At a minimum, this supports its effectiveness in diabetic patients with functioning pain receptors in the skin which accounts for approximately one-third to one-half of the nearly 26 million people that according to the American Diabetes Association are suffering from PDN. BDSI plans to prepare for a confirmatory study in the latter part of 2013 which could lead to data availability by the end of 2014. The PDN market is highly under-served by existing products, such as the oral medications Lyrica and Cymbalta. BDSI estimates annual peak sales potential for the product in excess of $300 million in the U.S.
Under terms of the agreement, BDSI made an upfront payment of $2 million to Arcion in the form of unregistered shares of BDSI common stock. No further milestone payments are due to Arcion until successful completion of the clinical development program and the filing of a New Drug Application (NDA).
"BDSI continues to make remarkable progress in advancing its pipeline of BEMA products, BUNAVAIL and BEMA Bupren
|SOURCE BioDelivery Sciences International, Inc.|
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